MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON PLUS TAP-ON,115V DOM-G136(DNA); SCALER, ULTRASONIC

Catalog Number 8184001

Device Problems Overheating of Device (1437); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where lack of water flow has caused an overheating insert.Since an overheating insert could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

While using a cavitron plus g136 they allege that they had no water flow and the handpiece gets warm, no injury resulted.

Manufacturer Narrative

000 evaluated,meets specifications;contact customer could not duplicate customer's complaint.Unit working within factory specs.Customer failed to send in handpiece during last repair and this repair.Issue most likely with handpiece.Also, advise customer to ensure water pressure to unit is at recommended 40 psi and insert(s) are free of damages, clogs, and are functioning.Replaced damaged/worn components and recalibrated unit to factory specs.No handpiece received for evaluation.Qa by (b)(6).

• Brand Name: CAVITRON PLUS TAP-ON,115V DOM-G136(DNA)
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18572976
• MDR Text Key: 333621459
• Report Number: 2424472-2024-00004
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: D00381840011
• UDI-Public: D00381840011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8184001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1